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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G55815
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2021
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) # k172288. Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Prior to distribution, all fusion omni-tome sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome pre-loaded sphincterotome. It was initially reported that this tome left a foreign body on the wire [guide] after it was exchanged out of the system. A piece of the device was left on the wire [guide] after it was exchanged out. This caused us to have to remove the wire [guide] to remove the foreign body. Per additional information received on 2/4/2022: there was a ring that was left on the wire [metal band detaches]. [subject of report]: the metal band detached on the wire [guide] after it was exchanged out and caused the physician to have to remove the wire [guide] to remove the foreign body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameFUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
Type of DeviceKNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key13661287
MDR Text Key290550749
Report Number1037905-2022-00097
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG55815
Device Catalogue NumberFS-OMNI-35-480
Device Lot NumberW4518470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
Treatment
PENTAX ENDOSCOPE, UNKNOWN MODEL
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